Arrow Left Publications

Publications on Non-Biological Complex Drugs

The first publications addressing the regulatory challenges associated with non-biological complex drugs (NBCDs) appeared in 2011, and TI Pharma - now Lygature - contributed knowledge from the start. A list of NBCD-related publications co-authored by our team can be found on this page.



  • Crommelin, D. J., & de Vlieger, J. S. (Eds.). Non-biological complex drugs: the science and the regulatory landscape 20Springer. (2015). 

Blog Posts

  • AAPS Blog. Characterization of Complex Drug Products: Can we keep up with complexity? (2016). [Blog post]
  • AAPS Blog. Continued Discussions on the Regulation of Complex Drugs: Are We Closer to Alignment? (2015). [Blog post]
  • AAPS Blog. Complex Drugs Generate Complex Discussions. (2013). [Blog post]
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